- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01077011
Acute Comfort and Blur Profile of a Lubricant Eye Drop Versus a Marketed Lubricant Eye Gel
November 18, 2016 updated by: Alcon Research
The purpose of this study is to compare the comfort and blurriness of an investigational lubricant eye drop with a marketed lubricant eye gel.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Documented diagnosis of dry eye
Exclusion Criteria:
- Must not have worn contact lenses within 12 hours preceding enrollment
- Must not have used any topical ocular drops or ointment within 24 hours preceding enrollment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Lubricant eye drop
|
1 drop in each eye, one time
|
ACTIVE_COMPARATOR: GenTeal Gel
|
1 drop in each eye, one time
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Three-minute visual blur profile
Time Frame: Through 3 minutes (post-instillation)
|
Through 3 minutes (post-instillation)
|
Overall Acceptability
Time Frame: Immediately upon instillation
|
Immediately upon instillation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Drop Comfort Upon Instillation
Time Frame: Immediately upon installation
|
Immediately upon installation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- http://www.aaopt.org/evaluation-efficacy-and-patient-acceptance-new-lubricant-eye-gel
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (ACTUAL)
January 1, 2010
Study Registration Dates
First Submitted
February 18, 2010
First Submitted That Met QC Criteria
February 25, 2010
First Posted (ESTIMATE)
February 26, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
November 21, 2016
Last Update Submitted That Met QC Criteria
November 18, 2016
Last Verified
January 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C-09-060
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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